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FDA Issues Draft Guidance for Clinical Trials Using Enrichment Strategies 07 January 2013 Personalized Medicine Bulletin The Food and Drug Administration (FDA) recently issued a guidance document related to the conduct of clinical trials to support approval of human drugs and biological... FDA and the Importance of Confidentiality 01 October 2012 BioPharm International Partner David Rosen authored an article that appeared in the October 2012 issue of BioPharm International titled "FDA and the Importance of Confidentiality." ... Newsletter for Leaders in the Medical Device Industry – May 2012 May 2012 Legal News: Medical Devices Counting Down to Patent Reform: Steps That Medical Device Companies Can Take to Prepare By Courtenay C. Brinckerhoff (cbrinckerhoff@foley.com) Although President... The Biologics Price Competition and Innovation Act: Implications for Implementation in Light of FDA Draft Guidance 16 February 2012 Legal News Alert: Life Sciences On February 9, 2012, after significant time had elapsed since the passage of the Biologics Price Competition and Innovation Act (BPCIA) of 2009, the FDA finally... Newsletter for Leaders in the Medical Device Industry – October 2011 02 November 2011 Legal News: Medical Devices The New Patent Law: The Rules Have Changed, Your IP Strategies Must Also Change By Barry L. Grossman (bgrossman@foley.com) As of September 16, 2011, the rules... Newsletter for Leaders in the Medical Device Industry – March 2011 24 March 2011 Legal News: Medical Devices Proposed Radio License Seeks to Advance Wireless Medical Device Innovation By Michael S. Kramer (mkramer@foley.com) The FCC has proposed a new experimental... Newsletter for Leaders in the Medical Device Industry – November 2010 22 November 2010 Legal News: Medical Devices FDA and CMS Look Toward Parallel Approvals; Public Comments Accepted Until December 16, 2010 By Judith A. Waltz (jwaltz@foley.com) Although both the FDA... Newsletter for Leaders in the Medical Device Industry – August 2010 02 August 2010 Legal News: Medical Devices Providing Reimbursement Advice Has Significant Risks for Manufacturers By Judith A. Waltz (jwaltz@foley.com) As part of product support, many device manufactures... Two Federal Circuit Decisions Clarify Availability of Patent Term Extension for Approved Drug Products 10 May 2010 Legal News Alert: Intellectual Property In two decisions issued May 10, 2010, the Federal Circuit clarified the rights of patentees to receive patent term extension (PTE) based on FDA approval of a new... 12next Related 1 2 3
FDA Regulation of Laboratory Developed Tests: Benefit or Unnecessary Burden? 24 February 2013 Personalized Medicine Bulletin The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine...
FDA Issues Draft Guidance for Clinical Trials Using Enrichment Strategies 07 January 2013 Personalized Medicine Bulletin The Food and Drug Administration (FDA) recently issued a guidance document related to the conduct of clinical trials to support approval of human drugs and biological...
FDA and the Importance of Confidentiality 01 October 2012 BioPharm International Partner David Rosen authored an article that appeared in the October 2012 issue of BioPharm International titled "FDA and the Importance of Confidentiality." ...
Newsletter for Leaders in the Medical Device Industry – May 2012 May 2012 Legal News: Medical Devices Counting Down to Patent Reform: Steps That Medical Device Companies Can Take to Prepare By Courtenay C. Brinckerhoff (cbrinckerhoff@foley.com) Although President...
The Biologics Price Competition and Innovation Act: Implications for Implementation in Light of FDA Draft Guidance 16 February 2012 Legal News Alert: Life Sciences On February 9, 2012, after significant time had elapsed since the passage of the Biologics Price Competition and Innovation Act (BPCIA) of 2009, the FDA finally...
Newsletter for Leaders in the Medical Device Industry – October 2011 02 November 2011 Legal News: Medical Devices The New Patent Law: The Rules Have Changed, Your IP Strategies Must Also Change By Barry L. Grossman (bgrossman@foley.com) As of September 16, 2011, the rules...
Newsletter for Leaders in the Medical Device Industry – March 2011 24 March 2011 Legal News: Medical Devices Proposed Radio License Seeks to Advance Wireless Medical Device Innovation By Michael S. Kramer (mkramer@foley.com) The FCC has proposed a new experimental...
Newsletter for Leaders in the Medical Device Industry – November 2010 22 November 2010 Legal News: Medical Devices FDA and CMS Look Toward Parallel Approvals; Public Comments Accepted Until December 16, 2010 By Judith A. Waltz (jwaltz@foley.com) Although both the FDA...
Newsletter for Leaders in the Medical Device Industry – August 2010 02 August 2010 Legal News: Medical Devices Providing Reimbursement Advice Has Significant Risks for Manufacturers By Judith A. Waltz (jwaltz@foley.com) As part of product support, many device manufactures...
Two Federal Circuit Decisions Clarify Availability of Patent Term Extension for Approved Drug Products 10 May 2010 Legal News Alert: Intellectual Property In two decisions issued May 10, 2010, the Federal Circuit clarified the rights of patentees to receive patent term extension (PTE) based on FDA approval of a new...